`
`
`EXHIBIT 1008(A)
`EXHIBIT 1008(A)
`
`

`

`UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria., Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`15/070,839
`
`03/15/2016
`
`AmarLULLA
`
`7590
`30652
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE500
`PLANO, TX 75024
`
`02/01/2017
`
`CRT/20632IUS
`(4137-04709)
`
`3973
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`MAIL DATE
`
`DELIVERY MODE
`
`02/01/2017
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`15/070,839
`
`Applicant(s)
`LULLA ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`THOR NIELSEN
`
`Art Unit
`1616
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 10/27/2016.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)O This action is FINAL.
`2b)~ This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)~ Claim(s) 1-30 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 1-30 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilwww.usoto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) ~ Notice of References Cited (PTO-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`
`3) 0 Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20170127
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`The instant application was filed on March 15, 2016.
`
`A Preliminary Amendment was filed on October 27, 2017, in which claim 23 was
`
`amended to correct a typographical error.
`
`Claims 1-30 are pending and under examination.
`
`The instant claims duplicate those filed in application 14/661700 (now
`
`abandoned). All claims of application 14/661700 were allowed after:
`
`(1) the Applicant filed five Declarations, by Dr. Malhotra dated 09/23/2010, by Mr.
`
`Copra dated 12/08/2011, by Dr. Rajan dated 08/16/2011, by Dr. Maus dated
`
`08/16/2011, and by Dr. Malhotra dated 09/23/201 O; and
`
`(2) the Applicant filed Disclaimers of patent term over US Patent Nos. 8,168,620
`
`and 8,163,723, and over Application serial No. 14/661, 720 which subsequently issued
`
`as US Patent No. 9,259,928.
`
`Rejection of all Claims
`
`All pending claims are rejected for reasons of record in the parental applications,
`
`especially 10/518,016. In brief, the instant claims are rejected under 35 USC 102 as
`
`anticipated by, or in the alternative under 35 USC 103 as obvious over the disclosure of
`
`Cramer (EP 0780127) (of record), optionally further in view of Modi (US 6,294,153) (of
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 3
`
`record), Malmqvist-Granlund et al. (US 6,391,340) (of record), and/or Alfonso et al. (US
`
`6,017,963) (of record). The explanation of disclosures of the prior art and rationales for
`
`combining the disclosures of references as stated in examinations of US applications
`
`No. 10/518,016; 12/879515; 14/661700; and 14/661720 are incorporated in this action
`
`by reference.
`
`Furthermore, all pending claims are rejected for obviousness type double
`
`patenting as explained below.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438,164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528,163 USPQ 644 (CCPA 1969).
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 4
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`A.
`
`Claims 1-30 are rejected as the ground of nonstatutory double patenting
`
`as being unpatentable over claims 3, 5-13, 15, 18, 22, 24, 26, 28-29, 37-43, and 45-48
`
`of U.S. Patent No. 8,168,620. Although the claims at issue are not identical, they are
`
`not patentably distinct from each other because the conflicting claims are drawn to
`
`compositions having the instantly claimed ingredients and are indicated for use for nasal
`
`administration for treatment. More particularly, the conflicting claim 6 is drawn to a
`
`composition having 0.001 to 1 wt./wt. % azelastine salt and 0.0357 to 1.5 wt./wt. %
`
`fluticasone propionate; claim 7 claims a composition further comprising a buffer, a
`
`preservative, a suspending agent, a thickening agent, a surfactant, an isotonic agent
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 5
`
`and combinations thereof; and claim 18 recites that the azelastine salt is azelastine HCI.
`
`One of ordinary skill in the art at the time of the invention would have found it obvious to
`
`formulate the instantly claimed composition using the disclosure of the limitations from
`
`the several claims of the conflicting patent.
`
`B.
`
`Claims 1-30 are rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 2 (which recites a method of use comprising
`
`intranasal administration of a composition having azelastine HCI and a fluticasone
`
`ester), claim 3 (which recites that the fluticasone ester can be propionate), claim 4
`
`(which recites that the method can use a nasal spray composition), claim 13 (which
`
`recites concentration ranges of the active ingredients), claims 15-21 (which recite the
`
`excipients), and 22-28 (which are directed to several excipients) of U.S. Patent No.
`
`8,163,723. Although the claims at issue are not identical, they are not patentably
`
`distinct from each other because one of ordinary skill in the art at the time of the
`
`invention would have found it obvious to formulate the instantly claimed composition
`
`using the disclosure of the limitations from the several claims of the conflicting patent.
`
`C.
`
`Claims 1-30 are rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 1 - 30 of US Patent No. 9,259,928. Although the
`
`claims at issue are not identical, they are not patentably distinct from each other
`
`because one of ordinary skill in the art at the time of the invention would have found it
`
`obvious to formulate the instantly claimed composition using the disclosure of the
`
`limitations from the several claims of the conflicting patent application. The conflicting
`
`claims are drawn to a method of use of the compositions of the instant application. The
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 6
`
`person of ordinary skill in the art would have found it obvious to make the compositions
`
`claimed in the US Patent No. 9,259,928 because the compositions are expressly recited
`
`in the method claims.
`
`Conclusion
`
`Claims 1-30 are rejected.
`
`For the purpose of compact prosecution, a telephone message was left for Mr.
`
`Carroll, attorney of record, regarding the need for filing the above-cited Declarations (in
`
`coherent form), arguments based on the Declarations, and Terminal Disclaimers, in this
`
`application.
`
`The Applicant has provided Information Disclosure Statements having 516 non(cid:173)
`
`patent literature or foreign references and 493 US Patent or Patent Application
`
`references. Some of the above-cited Declarations are provided by I OS, but some
`
`appear to be scrambled.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to THOR NIELSEN whose telephone number is (571 )270-
`
`3476. The examiner can normally be reached on 08:30-17:00.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.uspto.gov/interviewpractice.
`
`

`

`Application/Control Number: 15/070,839
`Art Unit: 1616
`
`Page 7
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Thor Nielsen/
`Patent Examiner
`AU 1616
`
`

`

`
`
`
`EXHIBIT 1008(B)
`EXHIBIT 1008(B)
`
`

`

`Atty. Docket: CR'J'/206321 US (4137-04709)
`
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Cipla Limited
`
`Serial No,
`
`15/070,839
`
`March 15, 2016
`
`Filed:
`
`For:
`
`§
`§
`§
`§ Examiner:
`§
`§ Confirmation No,:
`§
`COMBINATION OF AZELASTINE AND
`:FUJT!CASONE FOR NASAL ADMINISTRATJON §
`
`Group Art Unit
`
`1616
`
`Thor B. Nielsen
`
`3973
`
`Mail Stop: Arnendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313~1450
`
`CERTIFICATE 01'' SUBMISSION
`
`r hereby certify !ha! !his correspondence is bf,ing cfoctrnnirnlly ,ubmilted to the
`U.S. Patent and Trnd,,muk Office website, W.\.~'.W,JJ.~IJ_(~).,gQY, on
`
`RESPONSE TO
`OFFICE ACTION HATED FEU.RUARY l. 20t7
`
`Dear Sir:
`
`In response to the Office Action dated February l, 2017, Applicant respectfully requests
`
`reconsideration of the above-identified application.
`
`A Listing of Claims begins on page 2 of this papeL
`
`Remarks/Arguments begin on page 7 of this paper.
`
`4J0493-vl/4137-04 709
`
`1
`
`

`

`Atty. Docket: CRT/2fJ6321 US (4137-04709)
`
`Patent
`
`1.
`
`(Original)
`
`A nasal spray formulation, comprising:
`
`LISTING OF CLA[MS
`
`from 0.001 q;:·; (weight/weight) to 1 % (weight/weight) of azelastine hydrochloride;
`
`from 0.0357% (weight/weight) to LS% (weight/weight) of fluticasone propionate;
`
`one or more preservatives;
`
`one or more thickening agents;
`
`one or more surfactants; and
`
`one or more isotonization agents.
`
`(Original)
`
`The formulation of claim 1, \Vherein the formulation has a pH of 4.5 to
`
`about 6.5.
`
`3.
`
`(Original)
`
`The formulation of claim 1, wherein the formulation is an aqueous
`
`suspension.
`
`4.
`
`(Original)
`
`The formulation of claim 1, wherein the one or more preservatives
`
`comprise benzalkonium chloride.
`
`5.
`
`(Original)
`
`The formulation of clairn t, wherein the one or more preservatives
`
`comprise edetate disodium and benzalkonium chloride.
`
`(Original)
`
`The .formulation of claim 5, comprising from 0,002% (v-..reight/weight) to
`
`0.05% (weight/weight) of edetate disodium and from 0,002% (weight/weight) to (L0.5%
`
`(weight/weight) of benzalkonium chloride.
`
`7.
`
`(Original)
`
`The formulation of claim 1, wherein the one or rnore thickening agents
`
`comprise microcrystalline cellulose and carboxyrnethyl cellulose sodium.
`
`2
`
`

`

`Atty. Docket: CR11/20632f US (4137-04709)
`
`Patent
`
`8,
`
`(Original)
`
`The formulation of claim 7, comprising from 0.65% (weight/,,veight) to
`
`3% (weight/weight) of the one or more thickening agents.
`
`9,
`
`(Original)
`
`The formulation of claim 1, wherein the one or more surfactants comprise
`
`polysorbate 80.
`
`10,
`
`(Original)
`
`The formulation of dairn l, wherein the one or more isotonization agents
`
`comprise glycerine.
`
`11,
`
`(Original)
`
`The formulation of claim 10, comprising from 2.3% (vveight/\.veight) to
`
`2.(i¾) (weight/weight) of glycerine,
`
`12,
`
`(Original)
`
`The formulation of claim 4, wherein the one or more preservatives further
`
`comprise phenyl ethyl alcohol.
`
`13.
`
`(Original)
`
`The formulation of claim 12, comprising 0.25% (weight/'vveight) of phenyl
`
`ethyl alcolmL
`
`14,
`
`(Original)
`
`The formulation of claim 1, comprising edetate disodiurn, benzalkonium
`
`chloride, microcrystaHine cellulose, carboxymethyl cellulose sodium, polysorbate 80, glycerine,
`
`and phenyl ethyl alcohol.
`
`15,
`
`(Original)
`
`The for.mulation of claim 14, comprising:
`
`from 0.002% (weight/weight) to OJlYX? (weight/weight) of edetate disodium;
`
`fron1 0.()02% (weight/weight) to (i.05% (weight/weight) of benzalkonium chloride;
`
`from 0.65% (weight/'vveight) to 3% (weight/weight) of a combination of microcrystanine
`
`cellulose and carboxymethyl cellulose sodium; and
`
`from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine,
`
`3
`
`

`

`Atty. Docket: CRI1/20632I US (4137-04709)
`
`Patent
`
`16,
`
`(Original)
`"
`... _.
`
`'
`
`A nasal spray fon:nuiation, comprising;
`
`0.1 Si) (weight/weight) azelastine hydrochloride;
`
`from 0.0357% (weight/weight) to 1,5°4; (weight/weight) of t1uticasone propionate;
`
`from 0Jl02% (weight/weight) to 0.05% (weight/\veight) of edetate disodium;
`
`frmn O,Oo2c;1ci (weight/weight) to 0.029c; (weight/weight) of henzalkonium chloride;
`
`from 0.65% (weight/weight) to 3% (weight/weight) of a combination of microcrystalline
`
`cellulose and carboxymethyl cellulose sodium;
`
`polysorbate 80;
`
`2.3% (weight/weight) of glycerine; and
`
`0.25% (weight/\veight) of phenyl ethyl a1cohoL
`
`17~
`
`(Original)
`
`The formulation of claim 16, \Vherein the formulation has a pH of 4.5 to
`
`about 6,5,
`
`18,
`
`(Original)
`
`The formulation of daim 16, wherein the formulation is an aqueous
`
`suspension.
`
`19,
`
`(Original)
`
`A nasal spray product comprising the formulation of claim 1.
`
`20.
`
`(Original)
`
`A nasal spray product comprising the formulation of claim 16,
`
`2L
`
`(Original)
`
`The nasal spray product of claim 19, wherein from 0.03 rng to 3 rng of
`
`azelastine hydrochloride and from 0.05 mg to 0J5 rng of iluticasone propionate is released per
`
`indiv ldual actuation.
`
`4
`
`

`

`Atty. Docket: CRTi20632I US (4137-04709)
`
`Patent
`
`22,
`
`(Original)
`
`The nasal spray product of claim 20, wherein from 0,03 mg to 3 rng of
`
`azelastine hydrochloride and from 0.05 mg to (U5 mg of fluticasone propionate is released per
`
`individual actuation.
`
`23.
`
`(Previously Presented)
`
`The formulation of claim 8, wherein the one or rnore
`
`thickening agents comprise microcrystalline cellulose and carboxyrnethyl cellulose sodium.
`
`24,
`
`(Original)
`
`The fonnuJation of claim 28, wherein the thickening agent comprises from
`
`0,65% (weight/weight) to 3% (weight/weight) of microcrystal!ine cellulose and carboxyrnethyl
`
`cellulose sodium.
`
`25.
`
`(Original)
`
`The formulation of claim 1, wherein the one or more isotonization agents
`
`is present in an amount that a reduction in the freezing point of from 050 °C to 056 °C is
`
`attained in comparison to pure water.
`
`(Original)
`
`The formulation of claim 25, \Vherein the one or more isotonization agents
`
`comprise glycerine,
`
`(Original)
`
`The formulation of dairn 26, comprising from 2.3%, (weight/weight) to
`
`2.6% (weight/weight) of glycerine.
`
`28,
`
`(Original)
`
`A nasal spray formulation, comprising:
`
`from 0.001 % (weight/weight) to 1 % (weight/weight) of azelastine hydrochloride;
`
`from about 50 p,g/rnL to about 5 rng/mL of fluticasone propionate;
`
`from 0.002'?{; (weight/weight) to (l.05% (v.reight/weight) of benzalkonium chloride;
`
`from 0,002c;f (weight/weight) to 0.050r; (weight/weight) of edetate disodium;
`
`glycerine;
`
`5
`
`

`

`Atty, Docket; CRT/206321 US {4137-04709)
`
`Patent
`
`polysmbate; and
`
`a thickening agent;
`
`wherein the formulation has a pH of 4.5 to about 6,5,
`
`29.
`
`(Original)
`
`The formulation of claim 28, wherein the formulation 1s an aqueous
`
`suspension.
`
`30.
`
`(Original)
`
`A nasal spray product comprising the formulation of claim 29, wherein
`
`from 0,03 mg to 3 mg of azelastine hydrochloride and from 0.05 mg to 0.15 mg of fluticasone
`
`propionate is released per individual actuation.
`
`6
`
`

`

`A.tty, Docket: CRT/206321 US (4137-04709)
`
`Pa.tent
`
`REMARKS/ARGUMENTS
`
`Status of Claims
`
`Claims 1-30 are currently pending in this application,
`
`Applicant hereby requests further examination and reconsideration of the presently
`
`claimed application.
`
`Information Disclosure ,\'tatement
`
`Applicant thanks the Examiner for review and consideralion of the Information
`
`Disclosure Statements filed May 9, 2016 and October 27, 2016,
`
`Claim ReJections-35 U.S.C. §§ 102 & 103
`
`As set forth on page 2 of the Office Action, all pending claims stand rejected for reasons
`
`of record in the parental applications, especially 10/518,016, under 35 USC § 102 as anticipated
`
`by, or in the alternative under 35 USC§ 103 as obvious over the disclosure of Cramer, EP Patent
`
`0780127 (hereinafter "Cramer"), optionally further in view of Modi, U.S. Patent 6,294,153
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`(hereinaHer "Modi"), J'Vla1rnqvist-Gran1und, et al., U.S. Patent 6,391,340
`
`(hereinafter
`
`"Il,Jalmqvist-Granlund", and/or Alfonso, et al., U.S. Patent 6,017,963 (hereinafrer "Alj(mso"),
`
`Applicant hereby submits the following exhibits and declarations (previously submitted
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`in the Supplemental Response to Office Action dated June 22, 2015 in the previous application,
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`USSN 14/661,700):
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`(1.) Exhibits I-IV previously submitted in the response lo Office Action in the previous
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`application, lJSSN 10/518,016, on AU!:,'llSt 16, 2011;
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`

`

`Atty. Docket: CRTi206321 US (4137~04709)
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`Patent
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`(2) f't4alhotra II Declaration - Declaration of Geena Malhotra dated Septernber 23, 2010
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`(with Exhibits A-D);
`
`(3) 1'1alhotra 111 Declaration - Declaration of Geena Malhotra dated August 12, 2011 (with
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`Exhibits A-C);
`
`(4) Ra.fan Declaration
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`- Declaration of Dr. Sujeet Rajan dated August 16, 2011 (with
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`Exhibit A);
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`(5) Maus Declaration - Declaration of Dr. Joachim Maus dated August 16, 2011 (with
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`Exhibits A-H); and
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`(6) Chopra Declaration - Declaration of Mr. NikhD Chopra dated August _12, 2011 (with
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`Exhibit A).
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`Applicant respectfully submits that the submission of these declarations, along with the
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`folk.,\:ving remarks, overcome lhe § 102 and § 103 rejections and render the present application in
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`condition for allowance. Applicant respectfolly requests favorable consideration in the form of a
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`notice of allowance.
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`Independent claims 1, 16, and 28 each recite "fluticasone propionate." Cramer does not
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`disclose the claimed pharmaceutically acceptable ester of fiulicasone, specifically fluticasone
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`propionate. Rather, Cramer discloses on page 3, lines 15-18:
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`Glucocorticoid agents most useful to the present invention include those selected
`from
`the group consisting of beclomethasone, flunisolide,
`triamcinolone,
`fiuticasone, mometasone, budesonide, pharmaceutically acceptable salts thereof
`and mixtures thereof.
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`Thus, at most Cramer discloses, among other glucocorticoid agents, fluticasone and
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`pharmaceutically acceptable salts thereof. Cramer doc:,;_not disclose "iluticasone propionate" as
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`recited in the pending claims, and thus Cramer does not anticipate the pending claims,
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`8
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`Ail). Docket: CRT/206321 US (4137-04709)
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`Patent
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`Furthermore, independent claims 1, 16, and 28 each 1Tcite "a nasal spray formulation."
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`As will be discussed in more detail below, Applicant has provided herewith a declaration
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`establishing that Exmnple 3 of Cramer (previously identified by the Examiner as the closest
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`example of Cramer) is inoperable and unacceptable as a pharmaceutical formulation in a dosage
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`form suitable for nasal administration, In order to be anticipating, a prior art reference must be
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`enabling so that the claimed subject matter may be made or used by one skilled in the art See
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`Amgen Inc. v. Hoechst lvfarion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003) ("Long ago
`
`our predecessor court recognized that a non-enabled disclosure cannot be antic1patory (because it
`
`is not truly prior art) if that disclosure fails to 'enable one of skill in the art to reduce the
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`disclosed invention to practice,"' citing 1n re Borst, 52 CC.P,A. 1398, 345 F.2d 851 (CC.P,A,
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`1962)). Accordingly, the inoperahility of Cramer's closest example 3 as a nasal spray
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`formulation is further evidence that Cramer does not anticipate the pending claims,
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`Accordingly, Applicant respectfully submits that independent claims 1, 16, and 28, as
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`well as claims 2-15, 17-27, and 29-30 depending therefrom, are novel over Cramer and that the
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`§ 102 rejection has been overcome,
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`HlL1l&iRt:Hmun'l~l' Cratrt(t:[
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`Claim ReJections-35 U.S.C. § 103
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`The various § 103 claim rejections are premised upon the application of the primary
`
`reference, Cramer, alone or in combination with one or more of the secondary references, Afodi,
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`Malmqvist-Granlwu:f, and!orAlfonso.
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`9
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`

`A.tty, Docket: CR1'iW632I US (4137-04709)
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`Patent
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`obyiousness.
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`In order to establish a prima facie case of obviousness, the Office Action must establish
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`that the prior art teaches each and every element of the claimed invention, that the basis for any
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`modification and/or combinatio11 of the prior art be clearly articulated, and that such rnodification
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`and/or combination has a reasonable expectation of success. See C/raham v, John Deere Co, of
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`Kansas Cit_v, 383 U.S. 1, 22 (U,S, 1966) (a11 obviousness determination begins ,:vith a finding
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`that "the prior art as a whole in one form or another contains all" of the elements of the claimed
`
`invention); KSR int 'l C'o. v. Teleflex, Inc., 127 S. Ct 1727, 1741 (2007) ('"[R]ejections on
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`obviousness cannot be sustained by mere condusory statements; instead, there must be sorne
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`articulated reasoning with some rational underpinning to support the legal conclusion of
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`obviousness,"' (quoting 1n re Kahn, 441 F.3d 977, 988 (Fed. CiL 2006))); Lf;fe Technologies fnc,
`
`v. Clontech Laboratories inc,, 224 F3d 1320, 56 USPQ2d 1186, 1190 (Fed.Cir. 2000) ("[ f]or
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`the fprior art] to render the claimed invention obvious, there must have been, at the tirne the
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`invention was made, a reasonable expectation of success in applying [the prior arfs] teachings.''),
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`Applicant respectfuHy submits that the pending clairns are patentable over the cited
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`references because the Office Action fails to establish a prima facie case of obviousness ln that
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`Cramer, either alone or in combination, does not contain all the elements of the pending claims
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`and the ordinarily skilled artisan would not have a reasonable expectation of success in
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`modifying and/or combining Cramer given the inoperability thereof.
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`As noted above, each of the §HB rejections is premised upon the application of Cramer
`
`as the primary reference, The Examiner previously identified Example 3 of Cramer as the
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`10
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`Atty, Docket; Clff/206321 US (4137-04709)
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`Patent
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`closest prior art example, and Applicant's previous §Ll32 declaration (i,e., the Afafhotra fl
`
`Declaration) was alleged to be deficient for failure to test against Exarnple 3 of Cramer, 'While
`
`not admitting any previous deficiency, in an effort to substantively advance prosecution
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`Applicant provides herewith the § 1.132 Declaration of Geena Malhotra (the "Afalhotra 111
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`Declaration'') regarding Exarnple 3 of Cramer. As set forth in the Malhotra 111 Declaration,
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`Example 3 of Cramer was reproduced as described therein, and the formulation described in
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`Example 3 of Cramer was found to be inoperable and unacceptable as a pharmaceutical
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`formulation in a dosage form suitable for nasal administration. Specifically, as set forth i11
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`paragraph 9 of the lvfalhotra III Declaration:
`
`From the observations set forth in paragraph 8, it is conclusive that the
`9.
`formulation described in Example 3 of Crarner is inoperable and unacceptable as
`a pharrnaceutical formulation in a dosage frmn suitable for nasal administration
`for at least the following reasons:
`resuspending
`in
`difficulty
`and
`(A)
`Unacceptable
`settling
`horr10geneity of the active material in product is not expected to he maintained
`due to caking seen at the bottom of vial of the formulation;
`Unacceptable jet rather than desired spray mist - after actuation of
`(B)
`the nasal pump, the product comes out as kt (a stream of liquid forcefully
`shooting forth from the orifice) and nutJl spray (a mist of fine liquid particles),
`and due to which the drug is not expected to be suitably deposited on nasal
`mucosa; and
`It is widely known and accepted that
`Unacceptable osmolality -
`(C)
`nasal sprays are preferably isotonic (as is acknowledged by C'ramer at page 3,
`!:rH\k~inibk
`lines 8 and 49) rather
`than hypertonk.
`.Accordingly,
`the
`hypt~rosm9tic (i.e., 554 rnOsm/kg), h.YmTti1J1ig _____ dEW:\~~kI of the product is
`expected to give rise to irritation of the nasal mucosa,
`
`These experimental findings dearly establish that Cramer's Example 3 sirnply does not
`
`work as a nasal spray forrnulation_ A reference that lacks an enabling disclosure "may qualify as
`
`a prior art reference under §103, .hitLQ..QJv for wha! i~J!i~plnst•d h1: .lt." Reading & Bates Constr_
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`Co. v. Baker Energy Resources Corp,, 748 F.2d 645,652,223 USPQ 1168, 1173 (Fed.Cir. 1985)
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`(emphasis added), Thus, while Example 3 of Cramer rnay persist as prior art for purposes of an
`
`11
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`

`A.tty, Docket: CRT/206321 US (4137-04709)
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`Patent
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`obviousness analysis despite the demonstrated inoperability thereof, Example 3 can be cited only
`
`for what is disclosed in it - critically, a n011~working, rather than worki.ng, example, Therefore,
`
`for at least the reasons noted above, Cramer's Example 3 does. noi (:lisclose "a nasal spray
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`fommlation" and, as such, cannot be cited as teaching the same,
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`,1-\ccording1y, because Cramer
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`does not teach or suggest "a nasal spray formulation" as recited in the pending claims, Cramer
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`does not teach each a11d every element as required for a proper prima J;:icie case of obviousness,
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`Accordingly, the Office Action has failed to establish a prifna facie case of obviousness as to the
`
`pending claims.
`
`Applicant respectfully submits that none of the secondary references cures the major
`
`deficiencies outlined above for the primary reference, Cramer. Accordingly (and without
`
`conceding the propriety of any such combinations), none of the combinations of Cramer with
`
`any of the seco11dary references establish a prima facie case of obviousness as to the pending
`
`claims because such combinations do not leach each and every element of the pending claims,
`
`Accordingly, the Office Action has failed to establish a prima facie case of obviousness as to the
`
`pending claims,
`
`Furthermore, the inoperability of Cramer's Example 3 (which -..vas deemed to be the
`
`closest prior art example) would discourage a person skilled in the art from further
`
`experimentation, and therefore would teach away from any further rnodifications to Cramer or
`
`from combining Cramer with a secondary reference. "A reforence may be said to teach away
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`

`

`A.tty, Docket: CRT/W632l US (4137-04709)
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`Patent
`
`when a person of ordinary skill, upon reading the reference, would be discouraged from
`
`following the path set out in the reference, or would he led in a direction divergent from the path
`
`In re Gurley, 27 F,3d 551, 553 (Fed, Cir. 1994) (emphasis added), "References that teach away
`
`cannot serve to create a prima facie case of obviowmess." See McGinley v, Franklin Sports, 262
`
`F3d 1339, 1354 (Fed, Cir. 2001). Given that the pending claims are directed nasal spray
`
`formulations and Cramer's Example 3 is demonstrably unsuitable for such use, a person skilled
`
`in the art would be discouraged from following the path set forth in Cramer's Example 3 as such
`
`is unlikely to be productive of the result sought by Applicant. Accordingly, a prima facie case of
`
`obvio